NCT00001916 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Berenson JR, Lichtenstein A, Porter L, Dimopoulos MA, Bordoni R, George S, Lipton A, Keller A, Ballester O, Kovacs MJ, Blacklock HA, Bell R, Simeone J, Reitsma DJ, Heffernan M, Seaman J, Knight RD
Efficacy of pamidronate in reducing skeletal events in patients with advanced multiple myeloma. Myeloma Aredia Study Group. N Engl J Med. 1996 Feb 22;334(8):488-93.
Delmas PD
Bisphosphonates in the treatment of bone diseases. N Engl J Med. 1996 Dec 12;335(24):1836-7.
Michelson D, Stratakis C, Hill L, Reynolds J, Galliven E, Chrousos G, Gold P
Bone mineral density in women with depression. N Engl J Med. 1996 Oct 17;335(16):1176-81.

Bone Biopsy for Histomorphometry and Analysis of Bone Marrow Derived Osteoblast and Osteoclast Progenitors to Explore Mechanisms of Decreased Bone Mineral Density in Depression

Details for clinical trial NCT00001916

Clinical trial NCT00001916 - References